Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Light Source, Fiberoptic, Routine
510(k) Number K842609
Device Name R.L. MEDICAL TWIN LIGHT SOURCE
Applicant
TRIDAK DIVISION OF INDICON, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRIDAK DIVISION OF INDICON, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.1500
Classification Product Code
FCW  
Date Received07/05/1984
Decision Date 08/09/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-